Safety and Efficacy of Fecal Microbiota Transplantation

Study Purpose

The gut microbiota is critical to health and functions with a level of complexity comparable
to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have
been implicated in a number of disease states. Fecal microbiota transplantation (FMT),
defined as infusion of feces from healthy donors to affected subjects, is a method to restore
a balanced gut microbiota and has attracted great interest in recent years due to its
efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not
responding to standard therapies.
Recent studies have suggested that dysbiosis is associated with a variety of disorders, and
that FMT could be a useful treatment. Randomized controlled trial has been conducted in a
number of disorders and shown positive results, including alcoholic hepatitis, Crohn's
disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic
encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown
positive results in other disorders including Celiac disease, functional dyspepsia,
constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic
encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant
Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection,
radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA
enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.
Despite FMT appears to be relatively safe and efficacious in treating a wide range of
disease, its safety and efficacy in a usual clinical setting is unknown. More data is
required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a
pilot study to investigate the efficacy and safety of FMT in a variety of
dysbiosis-associated disorder.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Exclusion Criteria:

- Known contraindication to all FMT infusion method such as nasoduodenal tube insertion,
oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema
- Any conditions that may render the efficacy of FMT or at the discretion of the
investigators
- Current pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Interventions

Procedure: - Fecal Microbiota Transplantation

Fecal microbiota transplantation

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